The goal of this clinical research study is to see if the drug OROS Methylphenidate HCl (Concerta) can help to control fatigue in patients with breast, gastrointestinal, lymphoma, myeloma or lung cancer who are going through chemotherapy or hormonal treatment or have completed chemotherapy or hormonal treatment in the last 12 months. The safety of this drug will also be studied. Another goal of the study is to see how certain cytokines change while patients undergo chemotherapy or hormonal treatment.

Mean Difference Between Post-Methylphenidate and Post-Placebo Measurement [ Time Frame: At end of two 2-week treatment cycles (4 weeks total) ] [ Designated as safety issue: No ]

The primary endpoint is the "fatigue worst" score (range: 0 - 10) on the Brief Fatigue Inventory (BFI) at the end of two-week treatment (either Methylphenidate or placebo). "Worst fatigue" is defined as participants' rating of worst fatigue on a scale of 0 (no fatigue) to 10 (as bad as can imagine). Since each participant is expected to receive both 2-week of Methylphenidate or 2-week placebo at different times, they serve as their own control. The outcome is the difference in "fatigue worst" score between post-Methylphenidate measurement and post-Placebo measurement.

Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of < or = 2 at baseline

Patient has a life expectancy > or = 6 months from the start of the study

Patient is using acceptable birth control methods. Female participants (if of child bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) must use medically acceptable methods of birth control. Medically acceptable methods of contraception include abstinence, birth control pills, diaphragm with spermicide, condom with foam or spermicide, vaginal spermicidal suppository or surgical sterilization

Patient must speak and understand English

Patient has provided written informed consent to participate in the study prior to enrollment to the study

Exclusion Criteria:

History of hypersensitivity reaction to methylphenidate

History of or current seizure disorder, glaucoma, major psychiatric diagnosis, narcolepsy, Tourette's syndrome, tension or agitation

History of clinically significant cardiac disease.

Uncontrolled hypertension: has not been on a stable treatment dose for the past month, or has a systolic pressure consistently (defined as 3 consecutive blood pressure readings within the last 30 days) greater than 150 mm Hg or diastolic pressure consistently greater than 85 mm Hg

History of fibromyalgia

Use of alcohol while participating in the study

Current use of illicit drugs or history of alcohol or drug abuse and/or abuse potential (see protocol for criteria)

Moderate to severe depression (> or = 20 on Beck Depression Index II)

If taking antidepressants, no changes in dose and/or no start of new course of treatment in the last 30 days

A severe narrowing (pathological or iatrogenic), obstruction of the gastrointestinal tract, or gastrointestinal malabsorption

If taking anxiolytics, and/or hypnotics, no changes in dose and/or no start of new course of treatment in the last 30 days

Patients with nausea, vomiting, or diarrhea of Common Toxicity Criteria for Adverse Effects (CTCAE) grade III or higher

If taking anticonvulsants for sensory neuropathy (Gabapentin or Pregabalin), no changes in dose and/or no start of new course of treatment in the last 30 days

History of severe headaches within 30 days prior to enrollment

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516269